Description of Event or Problem · 1
ON (B) (6) 2010, STERILE PROCESSING AND DECONTAMINATION -(B) (6)- STAFF COMPLAINED OF A STRONG ODOR EMANATING FROM THE STERRAD AREA. THESE UNITS ARE SEGREGATED FROM OTHER DEVICES IN THE AREA AND WAS NOTICED UPON OPENING THE J&J ASP STERRAD 200 -(B) (4) CYCLES: 1193-. UPON REVIEW, THE LAST CYCLE HAD BEEN COMPLETED ON (B) (6) 2010. BIOMEDICAL ENGINEERING, THE FACILITY SAFETY OFFICER, AND INDUSTRIAL HYGIENIST WERE ALL NOTIFIED OF THE CONCERNS. ASP WAS NOTIFIED VIA PHONE OF THE EVENT ON (B) (6) 2010 BY THE FACILITY, BIOMED/ENGINEERING SERVICE. THERE WERE TWO COMPLAINTS FROM THE EXPOSED HEALTH CARE WORKERS -HCW- (B) (6) AND (B) (6). BOTH HCWS EXPERIENCED VISIBLE SYMPTOMS: (B) (4) C/O LIGHTHEADEDNESS AND HEADACHE. HE ALSO C/O ITCHING TO RIGHT UPPER EXTREMITY. (B) (4) WAS IN MILD RESPIRATORY DISTRESS WITH AIRWAY IRRITATION, COUGHING, SCORE THROAT, SEVERE HEADACHE, AND BURNING EYES. BOTH HCWS WERE RESOLVED OVER THE NEXT 24 - 96 HOURS POST EXPOSURE. (B) (4) HEADACHE WAS PROLONGED AND DISSIPATED AFTER 3-4 DAYS POST EXPOSURE. BOTH HCWS APPEAR TO BE RESOLVED, BUT LONG-TERM EFFECTS REMAIN UNCLEAR. ON (B) (6) 2010, THE APS TECHNICIAN ARRIVED AND MADE THE FOLLOWING ANNOTATIONS: RESOLVE TEXT: THE CUSTOMER COMPLAINED OF A BAD ODOR AFTER OPENING THE DOOR. I VERIFIED SYSTEM WAS WITHIN SPECIFICATIONS. I RAN AN EMPTY CYCLE AND VERIFIED PROPER OPERATION. THE SYSTEM MEETS ALL SPECIFICATIONS. THE END USER OPENED THE DOOR ON (B) (6) 2010 AND EXPERIENCED THIS ISSUE. ASP DOES NOT RECOMMEND A MONITORING SYSTEM ACCORDING TO THE FOLLOWING MACHINE SPECIFICATIONS, AIR EXCHANGES, ETC: HTTP://WWW.ASPJJ.COM/PRODUCTS_&_SERVICES/STERRAD/STERRAD_200/LITERATURE/AD-52365_A%20_STERRAD200_INSTALLSPECS.PDF. AT APPROXIMATELY 10:30 TODAY -05/24/2010-, AN (B) (6) EMPLOYEE NOTICED A STRONG ODOR EMANATING FROM THE STERRAD 200 -(B) (4)- UPON INITIAL OPENING AFTER THE UNIT WAS UNUSED OVER THE WEEKEND. I OVERHEARD THE TECHNICIAN COMPLAIN OF THE STRONG SMELL AND WAS ABLE TO WITNESS DIRECTLY THE PUNGENT, SOUR, VINEGAR-LIKE SMELL. UPON REMOVING THE EMPLOYEE AND MYSELF FROM THE AREA, I ASKED (B) (4) TO COME NEAR TO SEE IF IT WAS THE SAME SMELL EXPERIENCED ON (B) (6) 2010; AND SHE STATED THAT IT WAS THE SAME. ALL THREE STAFF IN THE AREA WERE IMMEDIATELY REMOVED FROM THE WORK AREA AND WAITED IN THE HALL/BREAKROOM FOR 15 MINUTES WHILE THE ODOR DISSIPATED. ONE EMPLOYEE HAD NO COMPLAINTS, BUT THE OTHER DID NOTICE SOME MILD EYE AND THROAT IRRITATION ALONG WITH SOME MILD LIGHT-HEADEDNESS. AT THIS POINT, A TECHNICIAN COMMENTED THAT THEY HAD SMELLED THE SAME ODOR THE PREVIOUS (B) (6) 2010-, AND WAS TOLD IT WAS NORMAL BY ANOTHER TECHNICIAN. BIOMED WAS CALLED -WHO NOTIFIED THE INDUSTRIAL HYGIENIST AND J&J ADVANCED STERILIZATION PRODUCTS [ASP]-. BOTH OF THE FACILITY STAFF CAME TO REVIEW, BUT DID NOT ENTER THE AFFECTED AREA. THE AREA WAS AGAIN EVALUATED FOR ANY REMNANTS OF THE ODOR AFTER FIFTEEN -15- MINUTES AND SMELLING LITTLE -NEAREST TO DEVICE- TO NONE, THE STAFF WERE ALLOWED TO RETURN TO THEIR WORK. THE J&J ASP STERRAD SERVICE REPRESENTATIVE HAS BEEN REQUESTED TO BE ONSITE NEXT TUESDAY MORNING -(B) (6) 2010- AT 0800 AFTER THE LONG HOLIDAY WEEKEND. (B) (6) STAFF WILL CONTINUE THEIR WORK AS NORMAL THROUGH THE WEEK AND ALLOW THE STERRAD SERVICE TEAM TO OPEN THE UNIT AT THAT TIME FOR REVIEW/DIAGNOSIS. BIOMEDICAL ENGINEERING AND SAFETY ARE WORKING WITH OTHER COMPANIES TO REVIEW A PASSIVE MONITORING BADGE SYSTEM FOR HYDROGEN PEROXIDE VAPORS TO SEE IF ANY EXISTING DEVICES ARE AVAILABLE AND APPLICABLE TO THIS SITUATION FOR FUTURE EMPLOYEE MONITORING.